Clip for implant deployment device

ABSTRACT

A surgical device for deploying a surgical implant includes a proximal portion and a distal portion. The distal portion includes a frame arm. A spring clip system is coupled to the frame arm and includes a pair of clips and a spring member. The spring member is connected to each of the clips and biases the clips towards a closed position. In the closed position, the clips are configured to retain the implant in contact with the frame arm.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 13/451,962, filed on Apr. 20, 2012, now U.S. Pat.No. 8,753,361, which is a continuation-in-part of U.S. patentapplication Ser. No. 12/891,962, filed on Sep. 28, 2010, now U.S. Pat.No. 8,758,373, which is a continuation-in-part of U.S. patentapplication Ser. No. 12/834,456, filed Jul. 12, 2010, now U.S. Pat. No.8,753,359, which is a continuation-in-part of PCT international patentapplication number PCT/IL2009/000188, filed Feb. 18, 2009, which claimsthe benefit of and priority to U.S. provisional patent application Ser.No. 61/029,386, filed Feb. 18, 2008. The present application also claimsthe benefit of and priority to U.S. provisional patent application Ser.No. 61/691,859, filed Aug. 22, 2012, which claims the benefit of andpriority to U.S. provisional patent application Ser. No. 61/691,860,filed Aug. 22, 2012, which claims the benefit of and priority to U.S.provisional patent application Ser. No. 61/691,863, filed Aug. 22, 2012,which claims the benefit of and priority to U.S. provisional patentapplication Ser. No. 61/691,864, filed Aug. 22, 2012, which claims thebenefit of and priority to U.S. provisional patent application Ser. No.61/691,866, filed Aug. 22, 2012, which claims the benefit of andpriority to U.S. provisional patent application Ser. No. 61/691,869,filed Aug. 22, 2012. The present application also claims the benefit ofand priority to U.S. provisional patent application Ser. No. 61/302,186,filed Feb. 8, 2010. The contents of each of these prior applications areincorporated by reference herein in their entirety.

FIELD OF THE INVENTION

This invention generally relates to a device and method for reversiblycoupling an implant to an implant deployment device.

BACKGROUND

An object of the present invention is to provide an apparatus and amethod for performing corrective surgery on internal wounds such as ahernia where invasion of the patient's body tissues is minimized andresultant trauma is reduced.

A hernia is a protrusion of a tissue, structure, or part of an organthrough the muscular tissue or the membrane by which it is normallycontained. In other words, a hernia is a defect in the abdominal wallthrough which a portion of the intra-abdominal contents can protrude.This often causes discomfort and an unsightly, visible bulge in theabdomen. When such a hernia defect occurs in the abdominal region,conventional corrective surgery has required opening the abdominalcavity by surgical incision through the major abdominal muscles. Whilethis technique provides for effective corrective surgery of the herniadefect, it has the disadvantage of requiring a hospital stay of as muchas a week, during which pain is frequently intense, and it requires anextended period of recuperation. After the conventional surgery,patients frequently cannot return to a full range of activity and workschedule for a month or more. Accordingly, medical science has soughtalternative techniques that are less traumatic to the patient andprovide for more rapid recovery.

Laparoscopy is the science of introducing a viewing instrument through aport into a patient's body, typically the abdominal cavity, to view itscontents. This technique has been used for diagnostic purposes for morethan 75 years. Operative laparoscopy is performed through tiny openingsin the abdominal wall called ports. In most surgical techniques, severalports, frequently three to six, are used. Through one port is insertedthe viewing device, which conventionally comprises a fiber optic rod orbundle having a video camera affixed to the outer end to receive anddisplay images from inside the body. The various surgical instrumentsare inserted through other ports to do the surgery that normally wouldbe performed through an open incision through the abdominal wall.Because the laparoscopic surgical techniques require only very smallholes through the abdominal wall or other portions of the body, apatient undergoing such surgery may frequently leave the hospital withinone day after the surgery and resume a full range of normal activitieswithin a few days thereafter.

In repairing hernia the physician needs to first deploy the implant andthen attach the implant to the tissue.

There are many patents and patent applications relating to attaching aprosthesis implant to a tissue via tacks. Each patent and patentapplication describes a different attachment mechanism via differentanchoring means (see for example U.S. Pat. No. 6,447,524). Traditionalanchors used in surgery include clips, staples, or sutures, and may alsobe referred to as tissue anchors. These devices are usually made of abiocompatible material (or are coated with a biocompatible material), sothat they can be safely implanted into the body.

Most tissue anchors secure the tissue by impaling it with one or moreposts or legs that are bent or crimped to lock the tissue into position.Thus, most traditional anchors are rigid or are inflexibly attached tothe tissue. For example PCT No. WO 07/021834 describes an anchor havingtwo curved legs that cross in a single turning direction to form a loop.Those two curved legs are adapted to penetrate tissue in a curvedpathway. U.S. Pat. No. 4,485,816 describes surgical staple made of shapememory alloy. The staple is placed in contact of the tissue and thenheated. The heating causes the staple to change its shape thus,penetrating the tissue.

U.S. Pat. No. 6,893,452 describes a tissue attachment device thatfacilitates wound healing by holding soft tissue together under improveddistribution of tension and with minimal disruption of the woundinterface and its nutrient supplies.

U.S. Pat. No. 6,517,584 describes a hernia implant which includes atleast one anchoring device made of shape memory material. The anchoringdevices are initially secured to the prosthesis by being interlacedthrough a web mesh constituting the prosthesis. The attachment isobtained by altering the attachment element's shape from rectilinear toa loop shape due to heat induced shape memory effect.

Yet other patent literature relates to devices for endoscopicapplication of surgical staples adapted to attach surgical mesh to abody tissue.

An example of such a teaching is to be found in U.S. Pat. No. 5,364,004;U.S. Pat. No. 5,662,662; U.S. Pat. No. 5,634,584; U.S. Pat. No.5,560,224; U.S. Pat. No. 5,588,581; and in U.S. Pat. No. 5,626,587.

There are a few patent and patent applications teaching the deploymentof implants. For example U.S. Pat. No. 5,836,961 which relates to anapparatus used for developing an anatomic space for laparoscopic herniarepair and an implant for use therewith. The apparatus of U.S. Pat. No.5,836,961 comprises a tubular introducer member having a bore extendingtherethrough. A tunneling shaft is slidably mounted in the bore and hasproximal and distal extremities including a bullet-shaped tip. A roundedtunneling member is mounted on the distal extremity of the tunnelingshaft. The apparatus comprises an inflatable balloon. Means is providedon the balloon for removably securing the balloon to the tunnelingshaft. Means is also provided for forming a balloon inflation lumen forinflating the balloon. The balloon is wrapped on the tunneling shaft. Asleeve substantially encloses the balloon and is carried by thetunneling shaft. The sleeve is provided with a weakened region extendinglongitudinally thereof, permitting the sleeve to be removed whereby theballoon can be unwrapped and inflated so that it lies generally in aplane. The balloon as it is being inflated creates forces generallyperpendicular to the plane of the balloon to cause pulling apart of thetissue along a natural plane to provide the anatomic space.

More patent literature can be found in PCT No. WO 08/065653 whichrelates to a device especially adapted to deploy an implant within abody cavity. The device is an elongate open-bored applicator andcomprises (a) at least one inflatable contour-balloon, (b) at least oneinflatable dissection balloon. The inflatable contour-balloon and theinflatable dissection balloon are adjustable and located at the distalportion. The elongate open-bored applicator additionally comprises (c)at least one actuating means located at the proximal portion. Theactuating means is in communication with the inflatable contour-balloonand the inflatable dissection balloon. The actuating means is adapted toprovide the inflatable contour-balloon and the inflatable dissectionballoon with independent activation and/or de-activation.

Although all the above described patents and patent applicationsdemonstrate attachment means or deployment means, none of the literaturefound relates to a reversible connection device which enable areversible coupling between the implant and the implant deploymentdevice.

Thus, there is still a long felt need for a device that will enable areversible connection between the implant and the implant deploymentdevice.

SUMMARY

It is one object of the present invention to provide an activereversible connection mechanism adapted to provide a reversibleattachment between a prosthetic implant and an implant deploymentdevice, wherein said attachment can be actively reversed withoutrequiring any application of force on said implant.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein said activereversible connection mechanism comprising at least one clip, hinge-likecoupled to said implant deployment device, adapted to attach saidimplant to said implant deployment device: Said clip is characterized byhaving at least three configurations: (i) a horizontal configuration inwhich said clip is substantially horizontal with respect to said implantdeployment device; (ii) a vertical configuration in which said clip issubstantially vertical with respect to said implant deployment device;and, (iii) a free motion configuration in which said clip is free torotate; such that (i) when said clip is in said horizontal configurationsaid attachment between said implant and said implant deployment deviceis obtained; (ii) when said clip is in said free motion configurationsaid detachment between said implant and said implant deployment deviceis obtained.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, additionallycomprising at least one locking bar characterized by at least twoconfigurations: (i) lock configuration in which said lock bar maintainssaid clip in said horizontal configuration; and, (ii) free configurationin which said locking bar enables said clip a free movement.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein said activereversible connection additionally comprising at least one detachmentactuator adapted to reversibly transform said locking bar from said lockconfiguration to said free configuration.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saidattachment between said implant and said implant deployment device isobtained once said locking bar is in its said lock configuration andsaid at least one clip is in said horizontal configuration such that thesame at least partially penetrates said implant.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saiddetachment is achieved by transforming said locking bar from said lockconfiguration to said free configuration via said at least onedetachment actuator.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saiddetachment actuator comprises a wire; further wherein said wire isattached to said lock bar.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saidtransformation of said clip from said vertical configuration into theirsaid horizontal configuration is performed manually by the physician orby the aid of a dedicated device.

It is another object of the present invention to provide a method forattaching a prosthetic implant to an implant deployment device. Themethod comprising steps selected, inter alia, from:

a. obtaining an active reversible connection mechanism adapted toprovide a reversible attachment between said prosthetic implant and saidimplant deployment device; wherein said attachment can be activelyreversed without requiring any application of force on said implant;said active reversible connection comprising

i. at least one clip, hinge-like coupled to said implant deploymentdevice, adapted to attach said implant to said implant deploymentdevice: Said clip is characterized by having at least threeconfigurations: (i) horizontal configuration in which said clip issubstantially horizontal with respect to said implant deployment device;(ii) a vertical configuration in which said clip is substantiallyvertical with respect to said implant deployment device; and, (iii) afree motion configuration in which said clip is free to rotate;

ii. at least one locking bar characterized by at least twoconfigurations: (i) lock configuration in which said lock bar maintainssaid clip in said horizontal configuration; and, (ii) free configurationin which said locking bar enables said clip a free movement; and,

b. providing said clips in said vertical configuration;

c. providing said locking bar in said lock configuration;

d. threading said implant through said clip;

e. transforming said clip into its said horizontal configuration therebyproviding said attachment between said implant and said implantdeployment device;

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of providing said activereversible connection with at least one detachment actuator.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of reversiblytransforming said locking bar from said lock configuration to said freeconfiguration via said detachment actuator; thereby enabling freerotation of said clip such that detachment between said implant and saidimplant deployment device is obtained.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of introducing saidimplant deployment device into a body cavity.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of detaching saidimplant from said implant deployment device.

It is another object of the present invention to provide the method asdefined above, wherein said detachment additionally comprising the stepsof reversibly transforming said locking bar from said lock configurationto said free configuration via said detachment actuator; therebyenabling said clip to rotate freely such that said detachment betweensaid implant and said implant deployment device is obtained.

It is another object of the present invention to provide a hernia kituseful in minimal invasive hernia surgery, comprising:

a. an implant;

b. an implant deployment device, adapted to deploy said implant withinthe abdominal cavity; and,

c. an active reversible connection mechanism for reversible attachingsaid implant to said implant deployment device;

wherein attachment can be actively reversed without requiring anyapplication of force on said implant.

It is another object of the present invention to provide the hernia kitas defined above, wherein said active reversible connection mechanismcomprising:

a. at least one clip, hinge-like coupled to said implant deploymentdevice, adapted to attach said implant to said implant deploymentdevice: Said clip is characterized by having at least threeconfigurations: (i) horizontal configuration in which said clip issubstantially horizontal with respect to said implant deployment device;(ii) a vertical configuration in which said clip is substantiallyvertical with respect to said implant deployment device; and, (iii) afree motion configuration in which said clip is free to rotate; suchthat (i) when said clip is in said horizontal configuration saidattachment between said implant and said implant deployment device isobtained; (ii) when said clip is in said free motion configuration saiddetachment between said implant and said implant deployment device isobtained.

It is another object of the present invention to provide the hernia kitas defined above, additionally comprising at least one locking barcharacterized by at least two configurations: (i) lock configuration inwhich said lock bar maintains said clip in said horizontalconfiguration; and, (ii) free configuration in which said locking barenables said clip a free movement.

It is another object of the present invention to provide the hernia kitas defined above, wherein said active reversible connection additionallycomprising at least one detachment actuator adapted to reversiblytransform said locking bar from said lock configuration to said freeconfiguration.

It is another object of the present invention to provide the hernia kitas defined above, wherein said attachment between said implant and saidimplant deployment device is obtained once said locking bar is in itssaid lock configuration and said at least one clip is in said horizontalconfiguration such that the same at least partially penetrates saidimplant.

It is another object of the present invention to provide the hernia kitas defined above, wherein said detachment is achieved by transformingsaid locking bar from said lock configuration to said free configurationvia said at least one detachment actuator.

It is still an object of the present invention to provide the hernia kitas defined above, wherein said detachment actuator comprises a wire;further wherein said wire is attached to said lock bar.

It is an object of the present invention to provide the hernia kit asdefined above, wherein said transformation of said clip from saidvertical configuration into their said horizontal configuration isperformed manually by the physician or by the aid of a dedicated device.

At least one aspect of this disclosure includes a system for closing anaperture in a biological tissue, the system including a proximal portionadapted to remain outside the body, a distal portion adapted to beinserted into the body, the distal portion including at least one framearm, and at least one clip spring system connected to the at least oneframe arm and configured to releasably retain a surgical implant,wherein each clip spring system includes two clips and at least onespring member attached to each clip, wherein the at least one clipspring system biases the clips towards a closed position.

In at least one aspect of this disclosure, the at least one clip furtherincludes a hook, wherein at least one spring member is connected to thehook.

In at least one aspect of this disclosure, the at least one clip furtherincludes a body portion, wherein the at least one spring member isconnected to the body.

In at least one aspect of this disclosure, each clip further includes alocking tab, wherein the at least one spring member is connected to thelocking tab.

In at least one aspect of this disclosure, the at least one springmember is removably attached to at least one of the clips.

In at least one aspect of this disclosure, the at least one springmember includes one or more of a coiled linear spring.

In at least one aspect of this disclosure, the at least one springmember includes one or more of a coiled torsion spring.

In at least one aspect of this disclosure, the at least one springmember includes one or more of a bendable member including at least onearm attached to at least one of the clips and an anchor portion fixed tothe frame arm, wherein the arm is configured to bend and provide arestoring force against at least one of the clips when at least one ofthe clips is in an open position.

In at least one aspect of this disclosure, the one or more bendablemember includes a V-shaped member.

In at least one aspect of this disclosure, the V-shaped members areformed from a single piece of metal rod.

In at least one aspect of this disclosure, the one or more bendablemembers includes a W-shaped member.

In at least one aspect of this disclosure, the W-shaped member is formedfrom a single piece of metal rod.

In at least one aspect of this disclosure, a clip system for releasablyretaining a mesh to an implant deployment device includes at least oneclip spring system connectable to the implant deployment device andconfigured to releasably retain a surgical implant, wherein each clipspring system includes two clips and at least one spring member attachedto each clip.

In at least one aspect of this disclosure, the at least one clip furtherincludes a hook, wherein at least one spring member is connected to thehook.

In at least one aspect of this disclosure, the at least one clip furtherincludes a body portion, wherein the at least one spring member isconnected to the body portion.

In at least one aspect of this disclosure, each clip further includes alocking tab, wherein the at least one spring member is connected to thelocking tab.

In at least one aspect of this disclosure, the at least one springmember includes at least one coiled linear spring.

In at least one aspect of this disclosure, the at least one springmember includes at least one coiled torsion spring.

In at least one aspect of this disclosure, the at least one springmember includes one or more of a bendable member including at least onearm attached to at least one of the clips and an anchor portion fixed tothe frame arm, wherein the arm is configured to bend and provide arestoring force against at least one of the clips when the at least oneclip is in an open position.

In at least one aspect of this disclosure, the bendable member includesa V-shaped member.

In at least one aspect of this disclosure, the V-shaped member is formedfrom a single piece of metal rod.

In at least one aspect of this disclosure, the one or more bendablemember includes a W-shaped member.

In at least one aspect of this disclosure, the W-shaped member is formedfrom a single piece of metal rod.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIG. 1A illustrates an example of a implant deployment device whichcomprises said active reversible connection mechanism;

FIGS. 2A-2D illustrate the internal operation of said active reversibleconnection mechanism;

FIGS. 3A-3E illustrate a method of using said active reversibleconnection mechanism for providing said reversible connection betweensaid implant and said implant deployment device;

FIG. 4A-4H illustrate an embodiment of a stapling apparatus adapted forproviding a reversible connection by the active reversible connectionmechanism;

FIG. 5 illustrates an embodiment of a staple return spring;

FIGS. 6A and 6B illustrate an embodiment of a clip spring system inaccordance with the present disclosure in a closed position and an openposition, respectively;

FIGS. 7A and 7B illustrate an embodiment of a clip spring system inaccordance with the present disclosure in a closed position and an openposition, respectively;

FIG. 7C is a perspective view of the embodiment of FIGS. 7A and 7B in aclosed position;

FIGS. 8A and 8B illustrate an embodiment of a clip spring system inaccordance with the present disclosure;

FIGS. 9A and 9B illustrate an embodiment of a clip spring system inaccordance with the present disclosure in a closed position and an openposition, respectively;

FIG. 9C is a perspective view of the embodiment of FIGS. 9A and 9Bhaving one clip in a closed position and another clip in an openposition;

FIGS. 10A and 10B illustrate an embodiment of a clip spring system inaccordance with the present disclosure in a closed position and an openposition, respectively;

FIGS. 11A and 11B illustrate an embodiment of a clip spring system inaccordance with the present disclosure in a closed position and an openposition, respectively;

FIG. 12 is a perspective view of a lock bar according to an embodimentof the present disclosure;

FIG. 13A is a perspective view of the clip spring system of FIG. 6A inthe closed position and the lock bar of FIG. 12 in an unlocked position;

FIG. 13B is a perspective view of the clip spring system of FIG. 6A inthe open position and the lock bar of FIG. 12 in a locked position; and

FIG. 13C is a perspective view of the clip spring system of FIG. 6A inthe closed position and the lock bar of FIG. 12 in the locked position.

DETAIL DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The following description is provided, alongside all chapters of thepresent invention, so as to enable any person skilled in the art to makeuse of the invention and sets forth the best modes contemplated by theinventor of carrying out this invention. Various modifications of thepresent disclosure should be apparent to those skilled in the art, sincethe generic principles of the present invention have been definedspecifically to provide means and method for creating a reversible andactive connection between an implant and an implant deployment device.

The present invention provides an active reversible connection mechanismbetween a prosthetic implant and an implant deployment device whereinsaid connection can be performed during a surgery at a standard surgeryroom by the medical staff.

Furthermore, the present invention provides means so as to enable thesurgeon to actively eliminate said attachment once detachment betweensaid implant deployment device and said implant is necessary.

It should be emphasized that some of the major advantages of the presentinvention, with respect to the prior art, is to provide a fast andintuitive method for creating a reliable connection between an implantand an implant deployment device in the surgery room. Embodiments of animplant include, but are not limited to, a surgical patch, a surgicalmesh, or other biocompatible implants usable in repairing a defect inbody tissue.

In addition, the present invention provides means to actively disconnectsaid implant from said implant deployment device, when saiddisconnection is desired without the need to exert large forces on saidimplant and/or said tissue.

The term “Hernia” refers hereinafter for umbilical hernia, hiatalhernia, ventral hernia, postoperative hernia, epigastric hernia,spiegelian hernia, inguinal hernia and femoral hernia, generally anyabdominal wall related hernia.

The term “hinge” or “hinge-like connection” refers hereinafter as to atype of bearing that connects two solid objects, typically allowing onlya limited angle of rotation between them. Two objects connected by anideal hinge rotate relative to each other about a fixed axis of rotation(the geometrical axis of the hinge). Hinges may be made of flexiblematerial or of moving components.

The term “hinge like connection” can refer to a standard hinge or to aliving hinge (i.e., a thin flexible hinge (flexure bearing) made fromplastic that joins two rigid parts together while allowing them to bendalong the line of the hinge).

The term “controlled deployment” refers hereinafter to an implantdeployment which is continuous. Thus, deployment using the presentlydisclosed implant deployment device is variable amongst a number ofdeployment levels between a fully opened position and a fully closedposition rather than a binary arrangement that does not include anyintermediate positions or levels between fully opened and fully closed.This is in contrast to some conventional deployment systems in which thedeployment of the implant relies upon the elasticity of a loop membersurrounding the implant such that the implant can be either fully foldedor fully unfolded. No intermediate stages are enabled. In the presentinvention, there can be several deployment stages.

The term “bidirectional” or “fully reversible deployment” refershereinafter to the deployment of the implant, which according to thepresent invention, is fully reversible. In other words, the implantdeployment is bidirectional, i.e., the implant can be fully folded(i.e., deployed within the body) and then, if the surgeon desires, theimplant can be fully unfolded simply by the reconfiguration of theflexible arms from the initial stage to the final stage and vice versa.

The term “minimally invasive surgery” refers hereinafter to proceduresthat avoid open invasive surgery in favor of closed or local surgerywith fewer traumas. Furthermore, the term refers to a procedure that iscarried out by entering the body through the skin or through a bodycavity or anatomical opening, but with the smallest damage possible.

The term “articulation” refers hereinafter to a joint or juncturebetween two segments of the device. The articulating means of thepresent invention provides the ability to better adjust the device tothe curvature of the treated tissue.

The term “orientation” refers hereinafter to the rotation of the meshwithin the abdominal cavity so as to fit to the hernia. Usually the meshis not symmetric in shape (e.g. rectangular or elliptical)—therefore ithas different directions. By rotating the mesh within the abdominalcavity—one can decide which direction is turned where.

The term “adjusting” refers hereinafter to rolling, folding, and windingof the implant, thus preparing and enabling the insertion of saidimplant into the abdominal cavity.

The term “active reversible connection” refers hereinafter to a couplingbetween the implant and the implant deployment device implant deploymentdevice in which the coupling/decoupling between the implant and theimplant deployment device is enabled by an act performed by the user(namely the physician). Once said user performed said act, saidcoupling/decoupling is canceled.

According to the present invention the coupling/decoupling is obtainedactively via the aid of dedicated clips which are characterized by atleast two configurations:

(a) substantially horizontal/parallel configuration (in which anattachment between the implant and the implant deployment device isprovided);

(b) substantially vertical configuration; and,

(c) a configuration in which the clips are free to rotate.

Before explaining the figures, it should be understood that theinvention is not limited in its application to the details ofconstruction and the arrangement of the components set forth in thefollowing description or illustrated in the drawings. The invention canbe carried out in various ways.

Reference is now being made to FIG. 1A illustrates an example of animplant deployment device 100 which comprises said active reversibleconnection mechanism.

Implant deployment device 100 is defined hereinafter as a surgicaldevice which can introduce an implant into a body cavity of a patient;implant deployment device 100 can deploy said implant such that it is atleast partially spared inside the body cavity; alternatively implantdeployment device 100 can only introduce said implant into the bodycavity without performing any deployment.

In general, implant deployment device 100 comprises at least twoportions: a distal portion 101 and a proximal portion 102. The proximalportion is adapted to remain outside the body, adjacently to the userand the distal portion 101 is adapted to be inserted into the body.

The distal portion comprises at least one frame arm 104 to which theimplant is attached. Each frame arm 104 comprises said active reversibleconnection mechanism which provides reversible attachment between eachframe arm 104 and the implant 106 such that said implant can berolled/folded on said distal portion 101, and inserted into thepatient's body cavity through a laparoscopic cannula or a smallincision.

It should be noted that the term reversible refers hereinafter to theability to both attach the implant to the implant deployment device andto decouple the same from the implant deployment device.

Said active reversible connection mechanism comprises at least one clip107. Said clip is coupled to said frame arm 104 by hinge tab 132. Saidactive reversible connection is covered by cover 131 which is attachedto the frame arm 104. Cover 131 comprises at least one hinge tab 132which is adapted to hold said clip 107 attached to frame arm 104 an toserve as a hinge allowing free rotation of said clip 107. Said hinge tab132 is inserted through hinge hole 133, located at clip 107 and throughhole 134, located at frame arm 104.

Reference is now being made to FIGS. 2A-2D which illustrate the internaloperation of said active reversible connection mechanism. For thepurpose of illustration only, cover 131 is removed from these drawings.

A locking bar 203 is located inside groove 204 at frame arm 104. Saidlocking bar 203 can move linearly inside said groove 204 and comprisesat least one groove 205. Said locking bar 203 is characterized by atleast two positions: free position, in which each of said groove/s 205is substantially located below said clip 107 (see FIGS. 2C and 2D), andlock position, in which said groove 205 is located away from said clip107 (see FIGS. 2A and 2B).

In the lock position of the locking bar 203, the clip 107 aresubstantially perpendicular to the frame arm 104; and in free positionof the locking bar 203, the clip 107 are free to rotate (hence, as willbe discussed hereinafter a detachment is enabled).

A disconnection wire 206 is attached to said locking bar 203. Said wire206 can be pulled proximally to the proximal portion 102 and is adaptedto transform said locking bar 203 from its said lock position into itssaid free position.

According to this embodiment, each clip 107 comprises at least 3sections: protruding portion (PP) 201 adapted to protrude through saidimplant during said connection process, hinge hole 133, and locking tab202 which is tilted toward frame arm 104.

Each of said clip 107 is characterized by at least two configurations:horizontal/parallel configuration in which said clip 107 issubstantially horizontal and parallel to said frame arm 104 (FIGS. 2B,2C) and vertical configuration in which said clip 107 is substantiallyvertical with respect to said frame arm 104 (FIGS. 2A and 2D).

At least one holding hole 207 is located at said locking bar 203 and isadapted to hold said clip 107 in its vertical configuration.

At least one niche 208 in located at frame arm 104 adapted toaccommodate said locking tab 202 of said clip 107 while the clip 107 isin its said horizontal/parallel configuration.

Reference is now being made to FIGS. 3A-3D illustrating a method ofusing said active reversible connection mechanism in order to providesaid reversible connection between said implant and said implantdeployment device 100. Again, for the purpose of illustration only,cover 131 was removed from these drawings.

FIG. 3A illustrates the initial state of said active reversibleconnection mechanism in which all of said clip 107 are in their verticalconfiguration and said locking bar 203 is positioned in said lockposition.

As can be seen in the figure, said locking tab 202 of each said clip 107is located inside said holding hole 207, therefore each clip 107 is heldin its said vertical configuration and can penetrate an implant 210whilst the last is mounted on top of said implant deployment device (seeFIG. 3B).

Once said implant is mounted, each of said clip 107 is transformed fromsaid vertical configuration into their said horizontal configuration(see FIG. 3C).

Said transformation can be achieved either manually (i.e., the physicianwill manually rotate the clips 107 thereby transforming them from saidvertical configuration into their said horizontal configuration) or bythe aid of a dedicated device.

Once said clip 107 is transformed to its horizontal configuration whilesaid locking bar is in its said lock position, said locking tab 202 isurged into niche 208. Since the locking tab 202 is titled inwardly, ifsaid clip 107 is pulled upwardly in this state, the locking tab 202 isstopped by the upper edge of said locking bar 203, therefore, therotation back to said vertical configuration of said clip 107 is limitedby said locking bar 203 and said clips 107 are locked in said horizontalconfiguration, holding said implant attached to said frame arm 104.

It should be pointed out that it is a unidirectional mechanism. In otherwords, if one tries to force clips 107 to its vertical configuration,locking tabs 202 will ‘bump into locking bar 203.

By further pulling said locking bar 203 towards the proximal portion theclips 107 are unlocked and can be rotated be back to its verticalconfiguration (see FIGS. 3D and 3E).

Once detachment between said implant 210 and said implant deploymentdevice in desired, locking bar 203 is pulled backward by wire 206,changing the position of said locking bar form its said lock positioninto its said free position (see FIG. 3D). In said free position of thelocking bar 203, the clips 107 are free to rotate (hence, as will bediscussed hereinafter, a detachment between the implant deploymentdevice and the implant is enabled).

Once locking bar 203 is positioned in said free position, said groove's205 is located below said clips 107, therefore said locking bar 202 isno longer limiting the movement of said clips 107 enabling their freemovement. In this state, detachment can be obtained by simply pullingsaid frame arm 104 away from said implant; as a result, said clips 107rotate back into their said vertical configuration and are released fromsaid implant (see FIG. 2E).

Reference is now made to FIG. 4A-4H, which illustrate an embodiment of astapling apparatus 400 adapted for providing said reversible connectionby said active reversible connection mechanism. Said stapling apparatus400 comprises a frame 401 which holds the distal portion 101 of animplant deployment device 100. Four staplers 403 are connected to theframe 401 at each cornet by four separate hinges (either standard orliving hinges). Each said stapler 403 is adapted to push down theimplant 210 through a pair of clip 107 and to transform said clips 107from a vertical position into a horizontal position (thus providing saidreversible connection). Stapling presses 404 are located at the end ofeach stapler inside groove 405 and adapted to push clip 107 intohorizontal position. Each pair of staplers 403 is connected via bridge407 in order to prevent lateral movement of said staplers 403 during thestapling process. A snap groove 406 is located at the center of theframe 401 and adapted to reversibly hold said implant deployment device100 attached to stapling apparatus 400 until said reversible attachmentis obtained.

Each pair of clip 107 is held in a vertical position by clip holder 402.Each said clip holder 402 is adapted to hold a pair of clip 107 invertical position in order to allow its insertion through the implant210 during the stapling process. In addition, clip holder 402 is adaptedthe hold the clips vertical during shipment in order to allow staplingin the operation room without the need of any preparation. Asillustrated in FIGS. 4B-4C, each clip holder 402 comprises two grooves408 which hold the clip 107 in a vertical position. Once staplingprocess is performed and the surgeon is lowering the stapler 403 towardthe implant, each clip holder 402 is pushed down and as a result it isalso moving laterally. In this state, since the clip 107 are extractedfrom groves 408, their transformation from vertical into horizontalposition is enabled; said lateral movement of said clip holder 402 isobtained as bulge 409 at clip holder 402 is sliding along bulge 410 atthe stapling frame 401 during the down movement of clip holder 402.

FIGS. 4D-4G illustrate the process of connecting the implant 210 to onepair of clip. At the initial stage (FIG. 4D), the clips are heldvertically by clip holder 402. Next, an implant 210 is places on top ofthe stapling apparatus (FIG. 4E); the stapler 403 is then lowered towardthe implant 210 by the surgeon (or other member of the medical staff);as a result the two clip 107 are penetrating through implant 210 andinto groove 405 (FIG. 4F). During the initial penetration, clip 107 isheld by clip holder 402, thus premature transformation from verticalinto horizontal position is prevented. Once the clip 107 are completelyinserted into said implant 210, clip holder 402 is positioned laterallyrelative to the clip 107 (as also described is FIGS. 4B-4C); at thisstage the surgeon push on stapler press 404 and lower it toward clip 107(FIG. 4G), as a result clip 107 position is transformed form verticalposition into horizontal position. Since the said lock bar 203 islocated at its said lock position, once clip 107 are substantiallyhorizontal position, they are locked in this stage, thus providing saidreversible connection between implant 210 and implant deployment device100. Once said connection is obtain with all clip 107, implantdeployment device is removed from SA 400.

FIG. 4H illustrates the configuration of stapling apparatus 400 duringshipment. In order to reduce package volume during shipment and to keepthe device ready for stapling, at least one, preferably two, packagingcaps 411 are utilized. Said caps 411 are reversibly attached to theframe 401, and adapted to retain stapler 403 in a substantiallyhorizontal position during device shipment. In addition, said caps 411also prevent down movement of stapler press 404, prevent lateralmovement of clip holder 402 and prevent non-deliberate extraction ofimplant deployment device 100 from frame 401.

Once the device in removed from its packaging during the surgery, saidpack caps 411 are removed by the medical staff in order to allowstapling of the implant 210 to the implant deployment device 100. Oncethe caps 411 are removed, the staplers 403 springs into horizontalposition allowing the placement of implant 210 onto the staplingapparatus 400 and implant deployment device 100.

In order to allow tight spreading of the implant 210 during surgery,said stapling process is preformed while implant deployment device 100is not completely opened; as a result, once implant deployment device iscompletely opened inside the abdominal cavity, it is stretched beyondits original dimension (as was during stapling) therefore tightspreading is obtained.

Reference is now being made to FIG. 5 which illustrates an embodiment ofa staple return spring 500. In general, staple return spring 500 isneeded in order to return clip 107 into horizontal position immediateafter detachment from the implant 210; this is necessary in orderprevent damage to internal organs by the sharp tip of clip 107 and inorder to prevent clip 107 from being caught at the trocar or at thetissue during device extraction.

Referring to FIGS. 6A and 6B, an embodiment of a clip spring system 600for use with an implant deployment device 100 (FIG. 1) is illustrated.Clip spring system 600 includes two clips 601, each clip 601 including ahook 603, similar to the protruding portion 201 of FIG. 2 as describedabove, a body 605 having a locking portion 607 similar in function tothe locking tab 202 of FIG. 2 as described above, and a hinge hole 611similar to the hinge holes 133 of FIG. 2 as described above. The clipspring system 600 also includes a spring member 609 operably connectedto each clip 601, and configured to provide a restoring force due tomaterial deformation of the spring member 609 to move the clips 601 froman open position (FIG. 6B) to a closed position (FIG. 6A). That is, thespring member 609 biases the clips 601 towards the closed position. Asherein described with respect to this and future embodiments, an openposition is any position where the hooks as herein described are not incontact with or in close proximity to the frame arm 104, and a closedposition is where the hooks are in contact with or in close proximity tothe frame arm to secure an implant to the frame arm. The spring member609 may take any suitable shape capable of providing a spring forceagainst the clips 601 when at least one of the hooks 603 is rotatedupwards and away from the frame arm 104. As shown in FIGS. 6A and 6B,spring member 609 is a single coiled spring attached to the clips 601,however, more than one spring may be used. Also, a torsion spring orcoiled spring may be used instead of a linear spring. For example, oneor more torsion springs may be inlayed in one or more of the hinge holes611 such that the spring restores the clips 601 to the closed position.The spring member 609 may be made from any suitable semi-rigid material,including but not limited to one or more of a metal, polymer, plastic,and/or shape memory material such as nitinol.

Referring to FIGS. 7A-7C, an embodiment of a clip spring system 700 foruse with an implant deployment device 100 is illustrated. Clip springsystem 700 includes two clips 701, each clip 701 including a hook 703,similar to the protruding portion 201 of FIG. 2 as described above, abody 705 having a locking portion 707 similar in function to the lockingtab 202 of FIG. 2 as described above, and a hinge hole 711 similar tothe hinge holes 133 of FIG. 2 as described above. The clip spring system700 also includes a spring member 709 operably connected to each clip701, and configured to provide a restoring force to move the clips 701from an open position (FIG. 7B) to a closed position (FIG. 7A). That is,the spring member 709 biases the clips 701 towards the closed position.The spring member 709 may take any suitable shape capable of providing aspring force against the clips 701 when at least one of the hooks 703 isrotated upwards and away from the frame arm 104. As shown in FIGS.7A-7C, spring member 709 operably contacts an upper surface of each clip701 of the clip spring system 700, and is generally U-shaped when undertension from the clips 701 being rotated into the open position (FIG.7B). Spring member 709 may further include an integral or removableanchor portion 713 (FIG. 7C) that connects to the frame arm 104. Thespring member 709 may be formed from a single piece of material, suchas, but not limited to, a single sheet of material. The spring member709 may be made from any suitable semi-rigid material, including but notlimited to one or more of a metal, polymer, plastic, and/or shape memorymaterial such as nitinol.

Referring to FIGS. 8A and 8B, an embodiment of a clip spring system 800for use with an implant deployment device 100 is illustrated. Clipspring system 800 includes two clips 801, each clip 801 including a hook803, similar to the protruding portion 201 of FIG. 2 as described above,a body 805 having a locking portion 807 similar in function to thelocking tab 202 of FIG. 2 as described above, and a hinge hole 811similar to the hinge holes 133 of FIG. 2 as described above. The clipspring system 800 also includes a spring member 809 slidably engagedwith each clip 801, and configured to provide a restoring force to movethe clips 801 from an open position (FIG. 8B) to a closed position (FIG.8A). That is, the spring member 809 biases the clips 801 towards theclosed position. The spring member 809 may take any suitable shapecapable of providing a spring force against the clips 801 when at leastone of the hooks 803 is rotated upwards and away from the frame arm 804.As shown in FIGS. 8A and 8B, spring member 809 includes at least onebendable arm 813 slidably contacting at least one of the clips 801 andan anchor portion 815 fixed to the frame arm 104. The spring member 809includes a V-shape that allows arms 813 to be bent toward each other,thereby creating a restoring force on clips 801 as a function ofmaterial resistance of the arms 813. As shown, the arms 813 are slidablyconnected to a top surface of body 805 or hook 803 of each clip 801 ofthe clip spring system 800. The spring member 809 may be made from anysuitable semi-rigid material, including but not limited to one or moreof a metal, polymer, plastic, and/or shape memory material such asnitinol.

Referring to FIGS. 9A-9C, an embodiment of a clip spring system 900 foruse with an implant deployment device 100 is illustrated. Clip springsystem 900 includes two clips 901, each clip 901 including a hook 903,similar to the protruding portion 201 of FIG. 2 as described above, abody 905 having a locking portion 907 similar in function to the lockingtab 202 of FIG. 2 as described above, and a hinge hole 911 similar tothe hinge holes 133 of FIG. 2 as described above. The clip spring system900 also includes a spring member 909 slidably contacting each clip 901,and configured to provide a restoring force to move the clips 901 froman open position (FIG. 9A) to a closed position (FIG. 9A). That is, thespring member 909 biases the clips 901 towards the closed position. Thespring member 909 may take any suitable shape capable of providing aspring force against the clips 901 when at least one of the hooks 903 isrotated upward away from the frame arm 904. As shown in FIGS. 9A and 9B,spring member 909 includes at least one bendable arm 913 slidablyattached to at least one of the clips 901 and an anchor portion 915fixed to the frame arm 104. The bendable member includes a W-shape thatallows arms 913 to be bent toward each other, thereby creating arestoring force on clips 901 as a function of material resistance of thearms 913. As shown, the arms 913 are slidably connected to a top surfaceof body 905 or hook 903 of each clip 901 of the clip spring system 900.Referring specifically to FIG. 9C, the anchor portion 915 may bedisposed on the opposite side of the frame arm 104 as the clips 901, andmay also be at least partially covered by frame arm 104. The springmember 909 may be made from any suitable semi-rigid material, includingbut not limited to one or more of a metal, polymer, plastic, and/orshape memory material such as nitinol.

The herein described spring members may be configured to communicatewith a bottom surface of the clips such that the spring member is biasedmove the clips to the closed position by applying a force to the lowersurface of the clip, or an extension disposed on a bottom surface of theclip as shown in FIGS. 10A-11B.

Referring to FIGS. 10A and 10B, an embodiment of a clip spring system1000 for use with an implant deployment device 100 is illustrated. Clipspring system 1000 includes two clips 1001, each clip 1001 including ahook 1003, similar to the protruding portion 201 of FIG. 2 as describedabove, a body 1005 having a locking portion 1007 similar in function tothe locking tab 202 of FIG. 2 as described above, and a hinge hole 1011similar to the hinge holes 133 of FIG. 2 as described above. The clipspring system 1000 also includes a spring members 1009 operablyconnected to each clip 1001, and configured to provide a restoring forceto move the clips 1001 from an open position, as shown in FIG. 10B, to aclosed position, as shown in FIG. 10A. That is, the spring member 1009biases the clips 1001 towards the closed position. The spring member1009 may take any suitable shape capable of providing a spring forceagainst the clips 1001 when at least one of the hooks 1003 is rotatedupwards and away from the frame arm 104. As shown in FIGS. 10A and 10B,spring members 1009 are a single coiled spring attached to the clips1001 at a lower surface of the clips 1001. Each spring member 1009 isattached to the frame arm 104 at an anchor point 1013. The spring member1009 may be made from any suitable semi-rigid material, including butnot limited to one or more of a metal, polymer, plastic, and/or shapememory material such as nitinol.

Referring to FIGS. 11A and 11B, an embodiment of a clip spring system1100 for use with an implant deployment device 100 is illustrated. Clipspring system 1100 includes two clips 1101, each clip 1101 including ahook 1103, similar to the protruding portion 201 of FIG. 2 as describedabove, a body 1105 having a locking portion 1107 similar in function tothe locking tab 202 of FIG. 2 as described above, and a hinge hole 1111similar to the hinge holes 133 of FIG. 2 as described above. The clipspring system 1100 also includes a spring members 1109 operablyconnected to each clip 1101, and configured to provide a restoring forceto move the clips 1101 from an open position, as shown in FIG. 11B, to aclosed position, as shown in FIG. 11A. That is, the spring member 1109biases the clips 1101 towards the closed position. The spring member1109 may take any suitable shape capable of providing a spring forceagainst the clips 1101 when at least one of the hooks 1103 is rotatedupwards and away from the frame arm 104. As shown in FIGS. 11A and 11B,spring members 1109 are bendable arms attached to the clips 1101 at alower surface of the clips 1101. Each spring member 1109 is eitherfixedly or rotatably attached to the frame arm 104 at an anchor point1113. The spring members 1109 are shown as separate members anchored tothe frame arm 104, but one ordinarily skilled would appreciate that thearms may be linked together in a manner similar to the V-type or W-typespring members as described herein, and configured to be attached to abottom surface of the clips 1101. The spring member 1109 may be madefrom any suitable semi-rigid material, including but not limited to oneor more of a metal, polymer, plastic, and/or shape memory material suchas nitinol.

Referring to FIG. 12, another embodiment of a lock bar 203 a for usewith an implant deployment device 100 is illustrated. As shown, lock bar203 a includes protrusions 209 a, 209 b formed from or attached to lockbar 203 a that extend at least partially away from the lock bar 203 a ina lateral direction that is away from the frame arm 104. Each protrusion209 a, 209 b may be a tab of material that is cut out of the lock bar203 a and bent outwardly to create a ramp-like cammed shaped as shown inFIG. 12. Each protrusion 209 a, 209 b may also be a separate piecepermanently or releasably attached to the lock bar 203 a.

Although the lock bar 203 a will discussed with respect to the clipspring system 600 that is shown in FIGS. 6A and 6B, the lock bar 203 ais usable with any of the clip spring systems disclosed herein.Referring now to FIG. 13A, the frame arm 104 includes the lock bar 203 aand the clip spring system 600. The lock bar 203 a is shown in anunlocked position and the clip spring system 600 is shown in the closedposition. The clips 601 are rotatable to the open position, as seen inFIG. 13B, which allows the clinician to attach the surgical implant 210(FIG. 3A) to the frame arm 104 by passing the surgical implant 210 overthe hooks 603 of the clips 601. This is the default configuration forthe implant deployment device 100 since it allows the clinician toattach the surgical implant 210 to the implant deployment device 100since the clips 601 are maintained in the open position due to theinteraction with the clips 601 and the lock bar 203 a in the lockedposition (FIG. 13B). Once the surgical implant 210 is abutting the framearm 104, the clips 601 are rotated to the closed position over theprotrusions 209 a, 209 b of the lock bar 203 as shown in FIG. 13C. Withthe clips 601 in the closed position and the lock bar 203 a in thelocked position, the locking portions 607 of the clips 601 contact uppersurfaces of the protrusions 209 a, 209 b of the lock bar 203 a, therebymaintaining the clips 601 in the closed position

Utilizing one or more embodiments of clip spring systems as hereindisclosed causes a biasing to the clips such that the hook portions ofthe clips tend to push up against the frame arm 104 and hold down anymesh attached thereto. The operation of the implant deployment device100 will be discussed with respect to FIGS. 13A-13C, but it is withinthe scope of the present disclosure that the lock bar 203 a may be usedwith any disclosed embodiment of the clip spring system. The clips maybe initially locked in an open position (e.g. FIG. 13B) allowing aclinician to pass the surgical implant 210 (e.g. a surgical mesh) overthe hooks 603 of the clip 601 and place the surgical implant 210 againstthe frame arm 104. After the surgical implant 210 has been coupled tothe implant deployment device 100 using the hooks 603, the cliniciansecures the surgical implant 210 to the implant deployment device 100 byrotating the clips 601 from the open and locked position (FIG. 13B) tothe closed and locked position (FIG. 13C). In this configuration, theimplant deployment device 100 is ready for use. When deployment of thesurgical implant 210 is desired, the clinician positions the implantdeployment device 100 in a surgical site and maneuvers the surgicalimplant 210 into a desired location (e.g. hernia). With the surgicalimplant 210 in the desired location, the clinician affixes the surgicalimplant 210 to body tissue using known techniques. Subsequently, theclinician actuates a release button (not shown) on the mesh deploymentdevice 100, which translates the lock bar 203 a from the locked position(FIG. 13A) to the unlocked position (FIG. 13A). With the lock bar 203 ain the unlocked position, the clinician moves the implant deploymentdevice 100 away from body tissue. Since the surgical implant 210 isaffixed to body tissue, movement of the implant deployment device 100and consequential movement of the frame arm 104, separates the frame arm104 from the surgical implant 210 and causes concurrent rotation of theclips 601 from the closed position to the open position. Thus, thesurgical implant 210 remains affixed to body tissue in the surgical siteand the implant deployment device 100 is separated from the surgicalimplant 210. Prior to removing the implant deployment device 100 fromthe surgical site, the clinician allows the spring bias of the springmember 609 to rotate the clips 601 from the open position to the closedposition. Once the clips 601 are in the closed position, the clinicianremoves the implant deployment device 100 from the surgical site.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein. Scope of theinvention is thus indicated by the appended claims rather than by theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

What is claimed is:
 1. A surgical instrument comprising: a proximalportion including a handle; a distal portion extending from the handleand adapted to be inserted into a body, the distal portion including aframe arm having a hinge tab; a clip pivotally secured to the frame arm,the clip defining a hinge hole, wherein the hinge tab is receivedthrough the hinge hole to rotatably support the clip about the hinge tabbetween an open position and a closed position, the clip configured toreleasably retain a surgical implant; a lock bar operatively associatedwith the frame arm, the lock bar translatable along a longitudinal axisof the frame arm between a locked position and an unlocked position, thelock bar maintaining the clip in one of the open position or the closedposition when the lock bar is in the locked position; and means fortransitioning the clip from the open position to the closed position,the means for transitioning the clip includes a spring memberoperatively coupled to the clip.
 2. The surgical instrument of claim 1,wherein the means for transitioning the clip urges the clip from theopen position to the closed position when the lock bar is in theunlocked position.
 3. The surgical instrument of claim 1, furtherincluding an implant attachable to the frame arm.
 4. The surgicalinstrument of claim 3, wherein the implant is retained to the frame armwhen the clip is in the closed position.
 5. The surgical instrument ofclaim 3, wherein the means for transitioning the clip urges the clipfrom the open position to the closed position when the lock bar is inthe unlocked position.
 6. The surgical instrument of claim 3, whereinthe clip remains in one of the closed or open positions when the lockbar is in the locked position.
 7. The surgical instrument of claim 1,further including a cover, wherein the hinge tab extends from the cover.